Feasibility and Acceptability of ReCognitionVR-based Cognitive Stimulation in Surgical Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Percentage of Patients Experiencing Treatment-emergent Adverse Events (TEAE)
研究概览
简要总结
This study aims to assess the feasibility, acceptability, and safety of using ReCognitionVR virtual reality-based software in older surgical patients. Results from this study will be used to inform the design of a future study in critically ill hospitalized patients at risk for delirium.
详细描述
Virtual reality (VR) imitates reality by creating an artificial 3-dimensional (3D) environment using computing technology or software. A virtual environment (VE) is created using this software with a headset, which cognitively stimulates the user's brain to think they are in an artificial world. Creating a VE allows flexibility and measurement of different types of stimuli while recording the various responses provided by users in the controlled VE. VR strengthens the brain's ability to focus, learn, and retain experience. VR for attention deficit disorders has been reported to have promising results. We followed in similar footsteps and designed and developed a novel, 3D simulated software platform prototype called ReCognition VR to provide VR-based cognitive exercises.
A feasibility clinical trial conducted by our group tested the ReCognitionVR cognitive interventions on older and young healthy volunteers (NCT05583903). The results of this study showed that ReCognitionVR-based cognitive exercises were feasible, acceptable, and tolerable by older healthy subjects. In stage 2 of our research study, we want to evaluate the safety, feasibility, acceptability, and tolerability of VR-based cognitive exercises in 60-year-old or older patients following abdominal surgery admitted to the surgical floor at Houston Methodist Hospital (HMH). Our premise is that VR-based cognitive stimulation software will allow the controlled delivery of structured cognitive exercises focusing on orientation, attention, memory, and executive functions. The system will allow customized frequency and duration of cognitive exercises based on the users' difficulty level in a delightfully relaxed environment with beach wave sounds.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥60 years of age
- •Scheduled to undergo the following abdominal surgeries (open or laparoscopic or robotic assisted): small bowel and large bowel surgery; cholecystectomy; Whipple procedure; pancreatectomy; splenectomy.
- •Richmond Agitation-Sedation Scale (RASS) Score 0
排除标准
- •Subjects with baseline cognitive impairment
- •Person with active psychiatric disorders and being treated with medications, especially schizophrenia
- •Person who is deaf or blind
- •Person with an underlying cognitive disorder or associated phobias (e.g., claustrophobia)
- •Person participating in other clinical trials involving drugs, biologics, devices, or behavioral interventions
- •Active seizure disorders
结局指标
主要结局
Percentage of Patients Experiencing Treatment-emergent Adverse Events (TEAE)
时间窗: Within 1 month of enrolling in the study
Percentage of participants who experience a treatment-emergent adverse event (TEAE) in the virtual reality software (experimental) arm compared to the Traditional Orientation Methods (control) arm.
次要结局
- Change From Baseline in Pulse Oximetry Oxygen Saturation After 10 Minutes(Baseline and 10 minutes)
- Change From Baseline in Respiratory Rate After 10 Minutes(Baseline and 10 minutes)
- Change From Baseline in Systolic Blood Pressure After 10 Minutes(Baseline and 10 minutes)
- Change From Baseline in Diastolic Blood Pressure After 10 Minutes(Baseline and 10 minutes)
- Change From Baseline in Respiratory Rate After Completion(Baseline and completion of the intervention, up to 2 hours)
- Change From Baseline in Systolic Blood Pressure After Completion(Baseline and completion of the intervention, up to 2 hours)
- Change From Baseline in Diastolic Blood Pressure After Completion(Baseline and completion of the intervention, up to 2 hours)
- Positive Confusion Assessment Method and/or 4 A's Test(Baseline to discharge from hospital, up to 3 months)
- Change in Visual Analog Scale (VAS) Pain Score(Enrollment in study to 24 hours after study enrollment)
- Change in Virtual Analog Scale (VAS) Pain Score Value Beginning to Mid-intervention(Virtual Reality Software arm: 10 minutes after beginning use; Traditional Orientation Methods arm: 8-16 hours after enrollment (one measure, window allowed for completing the measure))
- Change From Baseline in Pulse Oximetry Oxygen Saturation After Completion(Baseline and completion of the intervention, up to 2 hours)
研究者
Hina Faisal
Assistant Professor of Clinical Surgery
The Methodist Hospital Research Institute